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Executive Summary

BRIEF SUMMARY INFO MUST BE INCLUDED IN Rx AD EVEN IF PRDDUCT NAME NOT MENTIONED when the ad states that the product "is an effective treatment for a specific disease," FDA is informing industry in a statement, entitled "Clarification of FDA Policy on 'Institutional,' 'Corporate' or 'Health Message Advertising Practices." The agency asserts: "There appears to be a belief that omitting a specific drug name from an advertisement or other descriptive matter makes that material an 'institutional' or 'corporate' message and an exemption is provided from the requirements of the ]FD&C[ Act; it provides no such exemption." FDA points out that "some 'institutional' or 'corporate' advertisements may become promotional through undue emphasis, direct or indirect, on a product (or products of the type) manufactured by the sponsor, and subject to drug advertising requirements." FDA told "The Pink Sheet" that it reexamined its policy on Rx consumer advertising in light of, among other things, a recent television campaign by Hoechst-Roussel that addressed intermittent claudication but did not mention Hoechst-Roussel's Trental by name. The firm has received a reg letter from FDA. The agency explained that its policy has been to allow advertising that promotes public awareness: of companies as corporate entities; of the areas of research and development firms are involved in; of diseases companies have been instrumental in curing or ameliorating; and "in publicizing the signs and symptoms of diseases for which effective treatment (including in some cases non-drug therapy) are available." FDA said "the message relating to the specific diseases generally recommend to the reader that they see their physician for treatment of the condition discussed but they avoid reference to specific products manufactured by the sponsoring firm."

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